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Administrative data

Description of key information

Acute Oral Toxicity: LD50 = >5000 mg/kg bw 
Acute Dermal Toxicity: LD50 = >2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic information provided.
Reference:
Composition 0
Principles of method if other than guideline:
Ten fasted albino rats were administered >5000 mg/kg of sodium erythorbate in a 50% aqueous suspension. Clinical observations were noted at 3, 5 and 24 hrs post-dosing.
GLP compliance:
not specified
Test type:
standard acute method
Test material information:
Composition 1
Species:
rat
Strain:
other: albino
Sex:
not specified
Route of administration:
oral: unspecified
Vehicle:
water
Doses:
5000 mg/kg
No. of animals per sex per dose:
10
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Clinical signs:
The treated rats had soft, pasty stools within 3 hrs of dosing, followed in 2 hrs by marked diarrhea that persisted for 24 hrs.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The oral LD50 was >5000 mg/kg bw in this study.
Executive summary:

In an acute oral toxicity study, 10 fasted albino rats were given a single oral dose of 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone in a 50% aqueous suspension at a doses of 5000 mg/kg bw.

Oral LD50 = > 5000 mg/kg bw

The treated rats had soft, pasty stools within 3 hrs of dosing, followed in 2 hrs by marked diarrhea that persisted for 24 hrs.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw
Quality of whole database:
The key study was the only study available and was assigned a Klimisch score of 2.

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic information provided.
Reference:
Composition 0
Composition 0
Principles of method if other than guideline:
Sodium erythorbate(2000 mg/kg) was applied to the intact and abraded skin of six rabbits. Each test site was moistened with physiological saline just prior to dosing. After application of the test material, the exposure area was covered with a double layer of surgical gauze and a piece of rubber dam. The trunk of each rabbit was wrapped in a stockinette, which was secured to the body with tape. The dressings were removed after 24 hour, and the amount of residual sample and signs of localized irritation were noted. The exposure area was cleaned by thorough wiping, and the rabbits were observed for signs of toxicity for signs of toxicity for 48 and 72 hrs and 14 days.
GLP compliance:
not specified
Test type:
standard acute method
Test material information:
Composition 1
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Remarks:
test site was moistened with physiological saline just prior to dosing
Details on dermal exposure:
TEST SITE
- Area of exposure:Intact and abraded skin
- Type of wrap if used:The exposure area was covered with a double layer of surgical gauze and a piece of rubber dam. The trunk of each rabbit was wrapped in a stockinette, which was secured to the body with tape


REMOVAL OF TEST SUBSTANCE
- Washing (if done): The exposure area was cleaned by thorough wiping
- Time after start of exposure: After 24 hrs

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: no
Duration of exposure:
24 hrs
Doses:
2000 mg/kg
No. of animals per sex per dose:
6 animals
Control animals:
not specified
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No signs of toxicity were observed.
Clinical signs:
Beahavour was normal and no signs of toxicity were observed.
Body weight:
Bodyweight gain was normal.
Other findings:
- A substantial amount of residual compound was observed 24 hours after dosing. No erythema, edema, or other signs of dermal irritation were observed at five of six test sites. One rabbit (abraded skin) had slight (1+) erythema at 24 hours that cleared by 48 hours.

- Consumption of feed and water were normal.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The dermal LD50 was >2000 mg/kg bw in this study.
Executive summary:

In an acute dermal toxicity, 6 rabbits were dermally exposed (intact and abraded skin; occlusive exposure) to 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone for 24 hours at a dose of 2000 mg/kg bw. Animals then were observed for 14 days.

Dermal LD50 = > 2000 mg/kg bw

Behaviour, body weight gain, and consumption of feed and water were normal, and no signs of toxicity were observed. No erythema, edema, or other signs of dermal irritation were observed at five of six test sites. One rabbit (abraded skin) had slight (1+) erythema at 24 hours that cleared by 48 hours.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
The key study was the only study available and was assigned a Klimisch score of 2.

Additional information

Acute inhalation toxicity is waived as the test substance has very low vapor pressure and high melting point, so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no acute inhalation test was performed. Both acute oral and dermal studies (basic methodological details provided) had a Klimisch score of 2 and the results from both studies are acceptable to use in the human health risk assessment.


Justification for selection of acute toxicity – oral endpoint
Only 1 key study available.

Justification for selection of acute toxicity – inhalation endpoint
The test substance has very low vapor pressure and high melting point, so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no acute inhalation test was performed.

Justification for selection of acute toxicity – dermal endpoint
Only 1 key study available.

Justification for classification or non-classification

Based on the available information in the dossier, the substance 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone (CAS No. 6381-77-7) does not need to be classified for acute toxicity or specific target organ toxicity - single exposure when the criteria outlined in Annex I of 1272/2008/EC are applied.